Drug Development and Regulation — Flashcards

Flashcard 1: Me-too drugs are chemically related to the prototype or other chemical compounds that have an identical _____

Answer: mechanism of action

Flashcard 2: Examples of drugs eliminated by zero-order elimination include _____, ethanol, and aspirin (high concentrations)

Answer: phenytoin

Flashcard 3: Schedule _____ drugs are marketed under generic name only

Answer: W

Flashcard 4: Schedule _____ drugs include biological and special products

Answer: C and C1

Flashcard 5: _____ drugs are for the treatment or prevention of rare diseases with little commercial value for pharmaceutical companies.

Answer: Orphan

Flashcard 6: A pharmacologically inert substance used along with active ingredient in a formulation is called as an ____.

Answer: excipient

Flashcard 7: The loading dose of a drug is governed primarily by its _____

Answer: Vd

Flashcard 8: Freeze-sensitive vaccines include _____.

Answer: Hepatitis B, DPT, TT, Hib, PCV, and IPV

Extra: Freeze-sensitive vaccines (those containing aluminum adjuvants) lose potency if frozen. Examples include Hepatitis B, DPT, TT, Hib, PCV, and IPV. If freezing is suspected, the **Shake Test** is performed to determine if the vaccine is still usable. **Note:** Heat-sensitive vaccines (like OPV and Measles) are usually stored in the freezer compartment at the district level but are not "freeze-sensitive" in terms of damage; rather, they are "freeze-stable."

Flashcard 9: rubella vaccine(MMR) uses _____ strain

Answer: wistar RA27/3

Extra: 

Flashcard 10: Td vaccine contains _____ Lf units of diphtheria content

Answer: 2

Extra: Td (Tetanus and reduced-dose diphtheria) vaccine contains: - Tetanus Toxoid: 5 Lf - Diphtheria Toxoid: 2 Lf (The lowercase 'd' denotes reduced dose compared to 20-30 Lf in DPT/DT).